ML14121A534

Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure

ML14121A534
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/08/2014
From:	Steven Lynch Research and Test Reactors Licensing Branch
To:	Bynum R SHINE Medical Technologies
Lynch S
References
TAC MF2307
Download: ML14121A534 (3)

Text

May 8, 2014 Richard Vann Bynum, Ph.D.

Chief Operating Officer SHINE Medical Technologies, Inc 2555 Industrial Drive Monona, WI 53713

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, INC. - REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE (TAC NO. MF2307)

Dear Dr. Bynum:

By affidavit dated and submitted on March 17, 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14119A043), SHINE Medical Technologies, Inc. (SHINE), requested that information contained in the following document be withheld from public disclosure pursuant to the Title 10 of the Code of Federal Regulations (10 CFR),

Section 2.390:

Discussion Notes Associated with March 20, 2014 Meeting with NRC [U.S.

Nuclear Regulatory Commission]

The affidavit stated that the submitted information should be considered exempt from mandatory public disclosure for the following reasons:

a. The information sought to be withheld from public disclosure contained in the SHINE Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting with NRC is owned by SHINE, its affiliates or third parties to whom SHINE has an obligation to maintain its confidentiality. This information is and has been held in confidence by SHINE.

b. The information sought to be protected in the SHINE Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting with NRC is not available to the public to the best of my [SHINEs] knowledge and belief.

c. The information contained in the SHINE Medical Technologies, Inc.

Discussion Notes Associated with March 20, 2014 Meeting with NRC is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. The information that SHINE is requesting to be withheld from public disclosure includes trade secret[s], commercial information or information that is subject to export controls. SHINE limits access to these elements to those individuals with a need to know, and subject those individuals to maintaining confidentiality.

d. The proprietary information sought to be withheld from public disclosure in the SHINE Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting with NRC includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope facility,

R. Bynum process and system locations, and process details. This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings. Public disclosure of the information in the SHINE Medical Technologies, Inc.

Discussion Notes Associated with March 20, 2014 Meeting with NRC would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates or third parties to whom SHINE has an obligation to maintain its confidentiality.

We have reviewed your submittal in accordance with the requirements of 10 CFR 2.390 and, on the basis of the statements in the affidavit, have determined that the submitted information sought to be withheld contains proprietary commercial information and should be withheld from public disclosure.

Therefore, the version of the submitted information marked as proprietary will be withheld from public disclosure pursuant to 10 CFR 2.390(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended.

Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.

If the basis for withholding this information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.

If you have any questions regarding this matter, I may be reached at 301-415-1524.

Sincerely,

/RA/

Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-608 cc: James Costedio Licensing Manager SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

ML14121A534 NRR-084 OFFICE NRR/PRLB/PM NRR/PRLB/LA NRR/PRLB/BC NRR/PRLB/PM NAME SLynch PBlechman AAdams SLynch DATE 05/07/2014 05/06/2014 05/07/2014 05/08/2014